The Recall Desk

FDA (Devices) recall action 93800

MEDLINE INDUSTRIES, LP - Northfield recalled 49 products on 2024-03-06

The FDA (Devices) publishes a recall like this one as 49 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 49 pages.

Products
49
Announced
2024-03-06
Critical
6
Units
6,267,711

Why these products were recalled

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 49

  • HighFDA (Devices)··2024-03-06

    Medline Nursing Education Kits Recalled for Potential Lack of Sterility

    Medline Industries recalls 844 units of nursing education kits and trays due to potential lack of sterility in Nurse Assist irrigation solution components. Products distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline circumcision surgical kits recalled for sterility concerns

    Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.

    Product
    Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline recalls Centurion Laceration Trays for potential sterility defect

    Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.

    Product
    Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk

    Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.

    Product
    MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Centurion dialysis kits recalled due to sterility concerns

    Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2024-03-06

    Medline wound care trays recalled due to sterility defect

    Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Tracheostomy Care Trays Recalled for Sterility Issues

    Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.

    Product
    Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Suction Catheter Kits Recalled for Potential Sterility Defects

    Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,1
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    MEDLINE Irrigation and Tracheostomy Kits Recalled for Potential Sterility Failure

    MEDLINE Industries is recalling 385,028 units of suction catheter and tracheostomy care kits due to potential lack of sterility in Nurse Assist irrigation components. Affected kits were distributed in the US, Puerto Rico, Canada, UAE, and Panama.

    Product
    MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Prep Kits Recalled Due to Non-Sterile Components

    Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.

    Product
    Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure

    MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2024-03-06

    Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Instrument Trays Recalled for Potential Sterility Defect

    Medline Industries is recalling 228 medical device trays due to potential sterility defects in component solutions used in medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Tracheal Care Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.

    Product
    MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Medical Kits Recalled for Potential Sterility Defect

    Medline Industries is recalling multiple surgical and critical care kits due to a potential lack of sterility in component solutions (sodium chloride irrigation, sterile water for irrigation, and saline flush syringes). Non-sterile solutions could expose patients to infection.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYN
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Medical Device Kits Recalled for Potential Sterility Loss

    Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE18
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Centurion Eye Prep Kit Sterilization Defect Recall

    Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.

    Product
    Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2024-03-06

    MEDLINE Medical Device Kits Recalled for Potential Sterility Issues

    Medline Industries recalls multiple medical device kits and trays manufactured with components that may lack sterility. The affected solutions could be non-sterile, posing a potential safety risk.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    MEDLINE Serum Tear Kit Irrigation Solutions Recalled for Sterility Concerns

    Medline is recalling serum tear kit irrigation solutions due to potential sterility defects. The solutions may not be sterile, posing contamination risks during medical use.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Dialysis Irrigation Solutions Recalled for Potential Sterility Defect

    Medline Industries is recalling 10,391 units of dialysis kits and accessory packs due to potential sterility defects in component solutions. Non-sterile irrigation fluids could cause serious infection if used.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-03-06

    Medline Laceration Trays Recalled Due to Sterility Defect

    Medline is recalling laceration trays and medical kits with approximately 12,000 units due to sterility defects in component solutions. Non-sterile medical devices could pose infection risk during wound care procedures.

    Product
    Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
    Category
    Distribution
    1 state